Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer’s Disease

Brief Summary

Official Title: “A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer’s Disease”

The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people.

Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure, while the other half will undergo a "placebo" surgery where no medication will be injected. All study participants will be followed for at least two years after surgery.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2014

Interventions Used in this Clinical Trial

  • Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF
    • CERE-110 2.0 X 10^11 vg
  • Procedure: Placebo Surgery
    • Placebo Surgery

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: CERE-110
    • CERE-110: Adeno-Associated Virus Delivery of NGF
  • Sham Comparator: Placebo
    • Placebo Surgery

Outcome Measures for this Clinical Trial

Primary Measures

  • Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog)
    • Time Frame: 24 Months
      Safety Issue?: No

Secondary Measures

  • Neuropsychological Test Battery
    • Time Frame: 24 Months
      Safety Issue?: No
  • Mini-Mental State Examination (MMSE)
    • Time Frame: 24 Months
      Safety Issue?: No
  • Neuropsychiatric Inventory (NPI)
    • Time Frame: 24 Months
      Safety Issue?: No
  • Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL)
    • Time Frame: 24 Months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Diagnosis of mild to moderate Alzheimer's disease
  • Approved medications for Alzheimer's disease may be taken if the dose has been stable for 3 months
  • A study partner who can attend all study visits
  • Good general health
  • Medically able to undergo neurosurgery

Exclusion Criteria

  • Significant neurological disease other than Alzheimer's disease
  • Significant depression or other psychiatric disorder
  • Unstable medical conditions

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Ceregene
  • Collaborator
    • Alzheimer’s Disease Cooperative Study (ADCS)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul S. Aisen, M.D., Study Director, Alzheimer’s Disease Cooperative Study (ADCS)

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00876863